T/CGCPU 017-2021 Active Group standards

T/CGCPU 017-2021 CAR-T cell product clinical research quality control requirements

Publish Date: 2021-10-22 Implement Date: 2021-10-23 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CGCPU 017-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Health

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2021-10-22

Implement Date: 2021-10-23

Scope

Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 4. Quality control phases 5. Quality control objects 6. Quality control requirements 6.1 Quality control requirements 6.2 Project application 6.3 From project application to pre-launch 6.4 Project launch 6.5 Research implementation process after launch 6.6 From project completion to center summary form stamping 7. Quality control priorities 8. Quality control time and rectification time 8.1 Quality control time and rectification time 8.2 Project application 8.3 From project application to pre-launch 8.4 Project launch 8.5 Research implementation process after launch 8.6 From project completion to center summary form stamping 8.7 Causal quality control 9. Quality control plan 9.1 Quality control plan 9.2 Quality control frequency 9.3 Quality control ratio 10. Quality control results and management 10.1 Quality control records and rectification records 10.2 Quality control summary

Development Information

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